Osteoarthritis
Conditions
Keywords
Osteoarthritis, Veterans, Physical Therapy, Health Services Research
Brief summary
Osteoarthritis (OA) is a common cause of pain and disability. Physical therapy is a key part of treatment for OA, but VA Medical Centers are often limited in their capacity to provide physical therapy services for veterans with knee OA. The goal of this study is to perform a preliminary work on a group-based physical therapy program for veterans with knee osteoarthritis (OA), in preparation for a larger project. This work will allow us to assess the feasibility of conducting group-based physical therapy program and to plan a larger grant submission based on the findings of this initial study. We hypothesize that the group-based program will be feasible to administer and will result in improved pain and function.
Detailed description
Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. Physical therapy and ongoing exercise help to reduce pain and improve physical function. However, the majority of veterans with OA are physically inactive. Furthermore, physical therapy appointments in the VA health care system are a limited resource, with demand often exceeding supply, resulting in long wait periods and a limited number of visits (1 or 2) per patient. Extending physical therapy services to a larger number of veterans with OA, in a cost effective manner, may play a key role in improving outcomes in this large patient group. Objective: The objective of this pilot study is to perform preliminary evaluation of group-based physical therapy program for veterans with knee OA, in preparation for a larger grant submission. This pilot work will allow us to assess the feasibility of group-based sessions, refine the intervention session components as needed, assess the planned recruitment and enrollment methods, estimate the number of potentially eligible veterans at the Durham VAMC, and conduct sample size and power analyses for a larger clinical trial. Methods: All participants will be involved in a 12-week group-based physical therapy program, with study measures being obtained at baseline and immediately following program completion. Participants will be Durham VAMC patients with symptomatic knee OA. Our goal is to enroll 20 participants who complete the program and follow-up measures, but we may recruit up to 25 participants total, if some participants drop out of the program before completion. Participants will attend group physical therapy sessions bi-weekly for twelve weeks (total of six visits), with each session lasting approximately one hour. Two study team members, a licensed physical therapist and research assistant with training in exercise for knee OA, will lead each session. The research assistant will lead group exercises, and the physical therapist will assess the progress and monitor for any potential problems or special needs of individual patients. During the first 10-15 minutes of each group session, one study team member will talk with participants about a topic related to OA care, such as joint protection, weight management, joint injections and surgery, and stress management. The remainder of the session will involve group warm-up / stretching exercises, then a series of strengthening exercises tailored for patients with knee OA. Participants will also be instructed to perform stretching exercises daily and strengthening exercises three times total each week. Primary outcome measures will be self-reported pain and function. Statistical analyses will compare pre- and post-intervention pain and function, including effect size calculations to assist with sample size estimates for a larger study. Impact: This study is significant because it examines a novel health services delivery method for improving outcomes among patients with OA - a highly prevalent condition that is also one of the main causes of pain among veterans. Specifically, this pilot study is a key first step toward examining the efficacy and cost-effectiveness of a method for delivering physical therapy services to a larger number of veterans with OA. This delivery method could also be applied to other common orthopedic and neurologic conditions that require physical therapy service.
Interventions
12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Radiographic Evidence of Knee Osteoarthritis and a Clinician's Diagnosis * Current knee symptoms
Exclusion criteria
* Presence of other rheumatological conditions (such as rheumatoid arthritis and fibromyalgia) - Other health-related problem that would prevent safe participation in a physical therapy program - Currently undergoing physical therapy for knee OA, participation in another interventional study, scheduled or on waiting list for joint replacement surgery, resident of nursing home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline and Following 12-Week Intervention | Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Physical Therapy Group Physical Therapy Intervention
Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Group Physical Therapy |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.
Time frame: Baseline and Following 12-Week Intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Physical Therapy | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline Score | 43.3 units on a scale | Standard Deviation 14.6 |
| Group Physical Therapy | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 12-Week Score | 34.1 units on a scale | Standard Deviation 16 |